BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SilverHawk Peripheral Plaque Excision System

    Reg #: 2183870 · FEI: 2183870 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Medtronic, Inc.
    Registration Number
    2183870
    FEI Number
    2183870
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4600 Nathan Lane North
    City
    Plymouth
    State
    MN
    ZIP
    55442
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170191

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Catheter, Peripheral, Atherectomy MCW

    Proprietary Names

    SilverHawk Peripheral Plaque Excision System TurboHawk Peripheral Plaque Excision System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility